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Patient-Specific Instrumentation

Patient-Specific Knee Surgery for Osteoarthritis

N/A
Waitlist Available
Led By Edward M Vasarhelyi, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic knee osteoarthritis deemed most appropriately treated with total knee arthroplasty
Patient greater than 19 and less than or equal to 70 years of age
Must not have
History of prior open knee surgery, infection, or previous knee trauma
Simultaneous bilateral knee arthroplasty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 5 years and 10 years post-operatively
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the clinical outcomes and economic viability of using patient-specific instrumentation for total knee arthroplasty in obese patients.

Who is the study for?
This trial is for English-speaking adults aged 19-70 with obesity (BMI between 30 and 50) who have knee osteoarthritis best treated by total knee replacement. It's not for those with prior open knee surgery, infections, trauma, cognitive issues that affect questionnaire completion, inflammatory joint diseases, plans for bilateral knee replacements at once, fibromyalgia or chronic pain syndrome.
What is being tested?
The study is testing the economic and clinical effectiveness of Attune TruMatch Personalized Solutions Instruments in performing total knee replacements in obese patients. This involves comparing patient-specific instrumentation to standard methods using a randomized-controlled approach.
What are the potential side effects?
While specific side effects are not listed here as it's an instrument being tested rather than a drug, potential risks may include typical surgical complications such as infection, bleeding, blood clots or issues related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have knee pain from arthritis and need a knee replacement.
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I am between 20 and 70 years old.
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My BMI is between 30 and 50.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had previous knee surgery, infection, or injury.
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I am having or have had knee replacement surgery on both knees at the same time.
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I am able to complete questionnaires without any issues.
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I have chronic pain that lasts a long time.
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I have been diagnosed with fibromyalgia.
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I have a type of joint inflammation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 5 years and 10 years post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 5 years and 10 years post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Possible Change in Radiographic Alignment
Secondary study objectives
Assessment of Possible Change in Peri-operative metrics
Incremental cost-utility ratio
Patient-completed questionnaires

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Total Knee Arthroplasty with PSIExperimental Treatment1 Intervention
Total Knee Replacement with the use of the Attune TruMatch (TM) Patient-Specific Instrumentation
Group II: Total Knee ReplacementActive Control1 Intervention
Total Knee Replacement, as per Standard of Care

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
681 Previous Clinical Trials
431,146 Total Patients Enrolled
8 Trials studying Obesity
1,132 Patients Enrolled for Obesity
DePuy OrthopaedicsIndustry Sponsor
80 Previous Clinical Trials
25,763 Total Patients Enrolled
Johnson & Johnson Medical CompaniesIndustry Sponsor
5 Previous Clinical Trials
465 Total Patients Enrolled
Edward M Vasarhelyi, MDPrincipal InvestigatorLondon Health Sciences Centre
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Attune TruMatch (TM) Patient-Specific Instrumentation (Patient-Specific Instrumentation) Clinical Trial Eligibility Overview. Trial Name: NCT02177227 — N/A
Obesity Research Study Groups: Total Knee Replacement, Total Knee Arthroplasty with PSI
Obesity Clinical Trial 2023: Attune TruMatch (TM) Patient-Specific Instrumentation Highlights & Side Effects. Trial Name: NCT02177227 — N/A
Attune TruMatch (TM) Patient-Specific Instrumentation (Patient-Specific Instrumentation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02177227 — N/A
~17 spots leftby Dec 2025
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